Study for Safety and Efficiency of Therapeutic Angiogenes... | NCT00518934

Studies
Study for Safety and Efficiency of Therapeutic Angiogenesis for Patients With Limb Ischemia by Transplantation of Human Cord Blood Mononuclear Cell

NCT00518934

Sponsor

Samsung Medical Center

Status

Unknown status

Last Update Posted

Aug 21, 2007Estimated

Enrollment

Not provided

Phase

Phase 1Phase 2

Conditions

Ischemia

Interventions

Study for safety and efficiency of therapeutic angiogenesis for patients with limb ischemia by transplantation of human cord blood mononuclear cell

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Status Module

Record Verification Date

May 2007

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Not provided

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Aug 19, 2007

First Submission Date that Met QC Criteria

Aug 20, 2007

First Posted Date

Aug 21, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 20, 2007

Last Update Posted Date

Aug 21, 2007Estimated

Description Module

Brief Summary

The purpose of this study is to analyze the safety and efficiency of therapeutic angiogenesis for patients with limb ischemia by transplantation of human cord blood mononuclear cells.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

Not provided

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Study for safety and efficiency of therapeutic angiogenesis for patients with limb ischemia by transplantation of human cord blood mononuclear cell	Other

Eligibility Module

Eligibility Criteria

Inclusion Criteria:Patients with ischemic symptoms such as claudication, rest pain or nonhealing ischemic wound

Without evidence of improvement in response to conventional medical therapy
Not candidates for surgical intervention or radiologic intervention

Exclusion Criteria:

Malignant disease
More than 60 years old
Other significant medical conditions, including diabetes mellitus, hypertension, hyperlipidemia, etc.

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

60 Years

Standard Ages

ChildAdult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Dong-Ik Kim, Professor	Contact	82-2-3410-3467		dikim@skku.edu

Overall Officials

Name	Affiliation	Role
Dong-Ik Kim, Professor	Professor of division of vascular surgery, Samsung Medical Center, Sungkyunkwan University of School of Medicine	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Samsung Medical Center, Sungkyunkwan University School of Medicine	Recruiting	Seoul		135-710	South Korea

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
16439614	Background	Kim DI, Kim MJ, Joh JH, Shin SW, Do YS, Moon JY, Kim NR, Lim JE, Kim AK, Eo HS, Kim BS, Cho SW, Yang SH, Park CJ, Shim JS. Angiogenesis facilitated by autologous whole bone marrow stem cell transplantation for Buerger's disease. Stem Cells. 2006 May;24(5):1194-200. doi: 10.1634/stemcells.2005-0349. Epub 2006 Jan 26.

ID	Term
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

ID	Term
D000056	Accident Prevention
D000059	Accidents
D011634	Public Health
D004778	Environment and Public Health